A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel
Satraplatin is an oral platinum analog that is currently being evaluated in combination with
prednisone in a phase III clinical trial in patients with HRPC who have progressed following
one prior chemotherapy regimen.
Docetaxel is a taxane that is indicated for the treatment of patients with non-small cell
lung, breast, and prostate cancers. Specifically, it was recently approved in combination
with prednisone for the treatment of patients with hormone refractory prostate cancer
(HRPC). Docetaxel administered every 3 weeks was associated with a survival advantage versus
mitoxantrone. Docetaxel administered weekly showed an improvement in survival versus
mitoxantrone that was not statistically significant. However, it was better tolerated than
docetaxel administered every 3 weeks, with significantly less grade 3 and 4 toxicities,
especially neutropenia. The combination of satraplatin and weekly docetaxel may be a
feasible regimen for patients with chemotherapy-naïve HRPC and for patients with other
malignancies for which these medications show activity.
The objective of this study is to determine the optimum doses for satraplatin and weekly
docetaxel when the 2 drugs are given in combination.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the maximum tolerated dose (MTD) of satraplatin administered every 4 weeks in combination with docetaxel administered weekly (3 of 4 weeks)
Michael Petrone, MD
GPC Biotech Inc.
United States: Food and Drug Administration
|Sarah Cannon Research Institute||Nashville, Tennessee 37203|